Gershon MedTech Principal Gregg A. Jackson will be speaking at the Bio2Device Group Event on March 13 (Tue) about how digital health and mobile technology are transformating medical devices and the next steps needed to take this transformation to the next level. Event Topic: Developing Transformative Medical Devices in the Digital Health and Mobile Technology Era Event Date: 03/15/2016 - 8:30am Event Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, C
FDA 510k Clearance in 2 months? Yes, it’s possible.
We have recently completed a regulatory submission and approval in an extremely short amount of time. On average, it takes 5 months for the FDA to review and clear a medical device 510(k) application. Most people think they have a good chance of getting their 510(k) clearance within 90 days, but that’s not the reality. The reality is that only 28% of 510(k) submissions cleared in 2013 were done within 3 months. So, the 90